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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01813357




Registration number
NCT01813357
Ethics application status
Date submitted
9/12/2012
Date registered
19/03/2013
Date last updated
28/08/2020

Titles & IDs
Public title
Does Rosuvastatin Delay Progression of Atherosclerosis in HIV
Scientific title
Does Rosuvastatin Delay Progression of Atherosclerosis in People With HIV Infection at Moderate Cardiovascular Risk? A Multicentre Randomized, Double Blind Placebo-controlled Trial
Secondary ID [1] 0 0
ACTRN12612001082897
Secondary ID [2] 0 0
AH-491/12
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 0 0
Cardiovascular Disease 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rosuvastatin
Other interventions - Placebo

Placebo Comparator: Placebo - sugar pill that is encapsulated so as to appear identical to the active agent

Experimental: Rosuvastatin - Rosuvastatin 20mg daily


Treatment: Drugs: Rosuvastatin
encapsulated tablet 20mg daily

Other interventions: Placebo
Placebo arm included to maintain blinding
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression of Carotid Intima Media Thickness
Timepoint [1] 0 0
Baseline to week 96
Secondary outcome [1] 0 0
Rates of Adverse Events
Timepoint [1] 0 0
Will be assessed every 12 weeks and formally reported at 96 weeks of followup

Eligibility
Key inclusion criteria
- Age = 18 years

- Moderate cardiovascular disease (CVD) risk, (10-15% 10 year risk of CVD)

- HIV positive

- Stable combination anti-retroviral therapy (cART) with plasma HIV viral load
<200copies/ml for = 6 months
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Recommended use of lipid lowering therapy according to Australian guidelines

- Prior use of statin, fibrate, ezetimibe within the last six months

- Contraindication to statin use

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/07/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2018
Sample size
Target
Accrual to date
Final
84
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
Switzerland
State/province [1] 0 0
Geneve

Funding & Sponsors
Primary sponsor type
Other
Name
Bayside Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study is a randomised double blind placebo controlled trial comparing Rosuvastatin with
placebo in HIV positive people who are at intermediate cardiovascular risk.

It is possible that HIV positive people will receive a greater benefit from statins because
of their higher baseline levels of inflammation. Current Australian guidelines recommend
initiation of statin therapy on the basis of cholesterol level and the presence of other risk
factors for heart disease (such as diabetes) but do not take into account whether a patient
is infected with HIV. This study aims to determine what benefit HIV infected people will
receive from starting statin therapy earlier then currently recommended.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01813357
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jennifer Hoy
Address 0 0
Alfred health, Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01813357